This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the mcghan rtv saline-filled breast implant.
| Device | NATRELLE SALINE BREAST IMPLANTS |
| Classification Name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Generic Name | Prosthesis, Breast, Inflatable, Internal, Saline |
| Applicant | Allergan |
| Date Received | 1999-11-16 |
| Decision Date | 2000-05-10 |
| Notice Date | 2001-01-18 |
| PMA | P990074 |
| Supplement | S |
| Product Code | FWM |
| Docket Number | 01M-0012 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Allergan 2525 Dupont Dr. irvine, CA 92612 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990074 | Original Filing | |
| S050 | 2022-04-04 | Real-time Process |
| S049 | 2022-04-01 | 135 Review Track For 30-day Notice |
| S048 | 2021-06-30 | 30-day Notice |
| S047 | 2021-06-21 | 30-day Notice |
| S046 | 2021-05-26 | 30-day Notice |
| S045 | ||
| S044 | 2020-06-30 | 30-day Notice |
| S043 | 2019-11-04 | 30-day Notice |
| S042 | 2018-07-02 | 30-day Notice |
| S041 | 2017-10-02 | 30-day Notice |
| S040 | 2017-07-20 | 30-day Notice |
| S039 | 2017-06-07 | 30-day Notice |
| S038 | 2017-04-13 | 135 Review Track For 30-day Notice |
| S037 | 2017-03-01 | Normal 180 Day Track |
| S036 | 2016-11-23 | Real-time Process |
| S035 | 2016-11-07 | 30-day Notice |
| S034 | 2016-09-30 | 30-day Notice |
| S033 | 2016-09-07 | Special (immediate Track) |
| S032 | 2014-09-29 | 30-day Notice |
| S031 | 2014-09-15 | Normal 180 Day Track |
| S030 | 2014-08-06 | Real-time Process |
| S029 | 2014-05-30 | Normal 180 Day Track No User Fee |
| S028 | 2013-12-31 | Real-time Process |
| S027 | 2013-06-12 | 30-day Notice |
| S026 | 2013-05-20 | 30-day Notice |
| S025 | 2013-02-26 | 30-day Notice |
| S024 | 2012-05-30 | 30-day Notice |
| S023 | 2011-01-24 | Normal 180 Day Track No User Fee |
| S022 | 2009-10-13 | 30-day Notice |
| S021 | 2009-01-30 | 30-day Notice |
| S020 | 2008-09-04 | Normal 180 Day Track No User Fee |
| S019 | 2008-08-19 | 30-day Notice |
| S018 | 2007-02-23 | Normal 180 Day Track No User Fee |
| S017 | 2006-10-03 | Normal 180 Day Track No User Fee |
| S016 | 2004-10-25 | Normal 180 Day Track No User Fee |
| S015 | 2003-06-05 | Normal 180 Day Track No User Fee |
| S014 | 2003-02-13 | Normal 180 Day Track |
| S013 | 2002-08-09 | Normal 180 Day Track |
| S012 | 2002-07-23 | Normal 180 Day Track |
| S011 | 2002-06-17 | Normal 180 Day Track |
| S010 | 2001-11-14 | 30-day Notice |
| S009 | 2001-08-31 | Special (immediate Track) |
| S008 | 2001-07-23 | 30-day Notice |
| S007 | 2001-06-11 | 30-day Notice |
| S006 | 2001-04-17 | Normal 180 Day Track |
| S005 | 2001-01-29 | Normal 180 Day Track |
| S004 | 2000-12-18 | Normal 180 Day Track |
| S003 | 2000-11-29 | 30-day Notice |
| S002 | 2000-06-09 | Normal 180 Day Track |
| S001 | 2000-08-28 | Normal 180 Day Track |